U.S. patent application number 10/742483 was filed with the patent office on 2004-12-30 for implantable band having improved attachment mechanism.
Invention is credited to Albrecht, Thomas E., Byrum, Randal T., Jambor, Kristin L..
Application Number | 20040267288 10/742483 |
Document ID | / |
Family ID | 34316835 |
Filed Date | 2004-12-30 |
United States Patent
Application |
20040267288 |
Kind Code |
A1 |
Byrum, Randal T. ; et
al. |
December 30, 2004 |
Implantable band having improved attachment mechanism
Abstract
An implantable band for placement around an anatomical
passageway, such as the stomach or other lumen, includes a first
end portion with an opening configured to receive part of a second
end portion, with a retaining part included as part of the first or
second end portion.
Inventors: |
Byrum, Randal T.; (Milford,
OH) ; Jambor, Kristin L.; (Cincinnati, OH) ;
Albrecht, Thomas E.; (Cincinnati, OH) |
Correspondence
Address: |
FROST BROWN TODD, LLC
2200 PNC CENTER
201 E. FIFTH STREET
CINCINNATI
OH
45202
US
|
Family ID: |
34316835 |
Appl. No.: |
10/742483 |
Filed: |
December 19, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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60483353 |
Jun 27, 2003 |
|
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60507625 |
Sep 30, 2003 |
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Current U.S.
Class: |
606/151 |
Current CPC
Class: |
A61F 2220/0083 20130101;
A61B 17/1355 20130101; A61F 2002/30329 20130101; A61F 2220/0025
20130101; A61F 5/0066 20130101; A61F 2002/30467 20130101; A61F
5/003 20130101; Y10T 24/44162 20150115; A61B 2017/088 20130101;
A61F 2220/005 20130101; A61B 17/1327 20130101; Y10T 24/44094
20150115; A61F 2002/30448 20130101; A61F 5/0056 20130101; A61B
17/135 20130101 |
Class at
Publication: |
606/151 |
International
Class: |
A61B 017/08 |
Claims
What is claimed is:
1. An implantable band for treatment of a medical condition, the
band, comprising: (a) a strap configured to encircle an anatomical
passageway, said strap defining a circumferential direction
thereabout, said strap having an inner and outer surface; (b) first
and second end portions disposed at either end of said strap, said
first and second end portions configured to be attached to each
other so as to secure said strap adjacent the anatomical
passageway, said first and second end portions including respective
inner and outer surfaces which correspond to said inner and outer
surfaces of said strap; (c) first means integral to said strap for
attaching said first end portion to said second end portion; (d)
second means integral to said strap for maintaining said first end
portion attached to said second end portion in the event of failure
of said first means.
2. The band of claim 1, wherein said first means includes means for
establishing a final circumferential size of said band when said
first end portion is attached to said second end portion by said
first means.
3. The band of claim 2, wherein said first means comprise a lateral
opening disposed in said first end portion, and a portion of said
second end portion having a dimension greater than a corresponding
dimension of said lateral opening, whereby when said second end
portion is disposed through said lateral opening, said portion of
said second end portion resists withdrawal of said second end
portion from said lateral opening.
4. The band of claim 3, wherein said second means comprises a
retaining part extending from said second end and a lateral opening
disposed in said second end portion configured to receive and
retain said retaining part.
5. the band of claim 4, wherein said lateral opening disposed in
said second end portion has a key way configuration comprising an
opening head portion and an opening slot portion, and wherein said
retaining part comprises a stem extending from said second end
portion and a retaining head portion, said retaining head portion
being configured to be inserted through said opening head portion
and to not be withdrawn laterally from said opening slot portion,
said stem being configured to be advanced along said opening slot
portion after said retaining head portion is inserted through said
opening head portion.
6. The band of claim 1, wherein said second means comprise a
laterally extending opening disposed in said second end
portion.
7. The band of claim 6, wherein said second means comprise a
laterally extending opening disposed in said first end portion.
8. The band of claim 6, wherein said first means comprise a lateral
member extending laterally from said first end portion, said
lateral member defining a circumferentially extending opening
configured to receive said second end portion.
9. The band of claim 8, wherein said second means comprise a
laterally extending opening disposed in said first end portion, and
a member carried by one of said first and second end portions
configured to be inserted into said laterally extending opening of
said second end portion and said laterally extending opening of
said first end portion when saild laterally extending openings are
aligned.
10. The band of claim 9, wherein said second end portion includes a
step configured to abut said lateral member when said second end
portion is disposed in said circumferentially extending
opening.
11. The band of claim 8, wherein said lateral opening and said
second end portion are configured for a portion of said second end
portion to be disposed in said lateral opening.
12. An implantable band for treatment of a medical condition, the
band, comprising: (a) a strap configured to encircle an anatomical
passageway, said strap defining a circumferential direction
thereabout, said strap having an inner and outer surface; (b) first
and second end portions disposed at either end of said strap, said
first and second end portions configured to be attached to each
other so as to secure said strap adjacent the anatomical
passageway, said first and second end portions including respective
inner and outer surfaces which correspond to said inner and outer
surfaces of said strap; (c) a first latching mechanism integral to
said strap configured to attach said first end portion to said
second end portion; (d) a second latching mechanism integral to
said strap configured to maintain said first end portion attached
to said second end portion in the event of failure of said first
latching mechanism.
13. The band of claim 12, wherein said first latching mechanism is
configured to establish a final circumferential size of said band
when said first end portion is attached to said second end portion
by said first latching mechanism.
14. The band of claim 12, wherein said first latching mechanism
comprises a circumferentially extending opening formed in said
first end portion, said circumferentially extending opening
configure to receive at least a portion of said second end
portion.
15. The band of claim 14, wherein said second end portion has at
least one dimension which is larger than a corresponding dimension
of said opening, at least one of said opening and said second end
portion being sufficiently elastic for said second end portion to
be inserted at least partially through said opening.
16. The band of claim 15, wherein said second latching mechanism
comprises a lateral opening formed in said second end portion, and
an enlarged portion formed on said second end portion spaced from
said lateral opening, said enlarged portion configured to be
inserted at least partially into said lateral opening.
17. A method of implanting a band for treatment of a medical
condition, comprising the steps of: (a) providing a strap
configured to encircle an anatomical passageway, said strap having
first and second end portions disposed at either end of said strap;
(b) encircling a portion of the anatomical passageway with said
strap; (c) activating a first latching mechanism integral to said
strap configured to attach said first end portion to said second
end portion; and (d) activating a second latching mechanism
integral to said strap configured to maintain said first end
portion attached to said second end portion in the event of failure
of said first latching mechanism.
18. The method of claim 17, wherein the step of activating a first
latching mechanism establishes a final circumferential size of said
band about said anatomical passageway.
19. The method of claim 18, wherein the step of activating a first
latching mechanism comprises inserting said second end portion
through an opening formed in said first end portion.
19. The method of claim 17, wherein the step of activating a second
latching mechanism comprises inserting a portion of second end
portion into an opening formed in said first end portion.
20. The method of claim 17, wherein the step of activating a second
latching mechanism comprises inserting a portion of second end
portion into an opening formed in said second end portion.
21. An implantable band for treatment of a medical condition, the
band, comprising: (a) a strap configured to encircle an anatomical
passageway, said strap defining a circumferential direction
thereabout, said strap having an inner and outer surface; (b) first
and second end portions disposed at either end of said strap, said
first and second end portions configured to be attached to each
other so as to secure said strap adjacent the anatomical
passageway, said first and second end portions including respective
inner and outer surfaces which correspond to said inner and outer
surfaces of said strap; (c) said first end portion including at
least one first opening configured to receive part of said second
end portion therein, said part of said second end portion being
configured to be disposed in said at least one first opening; (d)
at least one of said first end portion and said second end portion
including a retaining part, said retaining part configured to
connect to at least one of said first end portion and said second
end portion so as to resist withdrawal of said part of said second
end portion from said at least one first opening.
22. The band of claim 21, wherein said retaining portion comprises
the distal end of said second end portion.
23. The band of claim 21, wherein said first end portion comprises
a lateral member extending laterally from said first end portion,
and wherein said at least one first opening is defined by said
lateral member and extends in said circumferential direction.
24. The band of claim 23, wherein said second end portion includes
an enlarged portion which has a transverse dimension that is larger
than a corresponding dimension of said first opening.
25. The band of claim 23, wherein said second end portion includes
an enlarged portion which has height and width dimensions which
correspond to dimensions of said first opening at least one of said
height and width dimensions being larger than the corresponding
dimension of said first opening.
26. The band of claim 21, wherein a portion of said second end
portion defines a laterally extending second opening, said
retaining part being configured to connect to said second end
portion by being disposed at least partially in said laterally said
second opening.
27. The band of claim 21, wherein said retaining part includes two
spaced apart enlarged portions.
28. The band of claim 27, wherein said two enlarged portions are
spaced apart a distance such that, when such retaining part is
disposed in said second opening, at least a portion of each of said
enlarged portions is not disposed within said second opening.
29. The band of claim 28, wherein a portion of at least one of said
enlarged portions is disposed in said second opening.
30. The band of claim 28, wherein one of said inner and outer
surfaces of said first end portion includes a recess shaped
complementarily to a portion of said enlarged portions.
31. The band of claim 27, wherein said enlarged portions are
generally spherical.
32. The band of claim 23, wherein said first end portion includes a
second opening and said second end portion includes a third
opening, said second opening and said third opening being mutually
alignable when said part of said second end portion is disposed in
said at least one first opening.
33. The band of claim 32, wherein said retaining part has a distal
end configured to be disposed through said second and third
openings when said second and third openings are aligned.
34. The band of claim 33, wherein said distal end comprises a
flared tip.
35. The band of claim 33, wherein said retaining part comprises an
arm which carries said distal end.
36. The band of claim 35, wherein said arm is connected to at least
one of said first end portion and said second end portion by a
living hinge.
37. The band of claim 23, wherein the other of said first and
second end portions which does not include said retaining part
includes a second opening, said retaining part configured to engage
said second opening.
38. The band of claim 21, wherein said retaining part includes at
least one lateral member extending laterally from at least one of
said first and second end portions.
39. The band of claim 38, wherein the other of said first and
second end portions from which said at least one lateral member
does not extend includes a second opening shaped complimentarily to
said at least one lateral member.
40. The band of claim 39, wherein said at least one lateral member
includes an enlarged distal end.
41. The band of claim 38, wherein said at least one lateral member
extends from said first end portion.
42. The band of claim 38, wherein said first and second end
portions configured to be attached to each other so as to secure
said strap adjacent the anatomical passageway with, said first and
second end portions extending in a non-circumferential outward
direction when attached together.
43. The band of claim 21, wherein said second end portion includes
said retaining part, said retaining part comprising a tip and a
base, said base being wider than said tip and wider than a
corresponding dimension of said at least one first opening.
44. The band of claim 43, including at least one lateral member
extending laterally from at least one of said first and second end
portions, said at least one lateral member being configured for
said retaining part to connect thereto.
45. The band of claim 44, wherein said at least one lateral member
defines a transverse opening, said transverse opening being
configured to receive said base.
46. The band of claim 21, wherein said first end portion terminates
in two spaced apart end members which extending in the
circumferential direction which define a gap therebetween, and said
at least one first opening comprises two spaced apart aligned
openings, each defined by a respective end member.
47. The band of claim 46, wherein said second end portion
terminates in a transversely extending member, said transverse
member being shaped complementarily to said two spaced apart
aligned openings.
48. The band of claim 47, wherein said retaining part extends
outwardly from said second end portion adjacent said transverse
member.
49. The band of claim 48, wherein said second end portion includes
a living hinge interposed between said strap and said retaining
part.
50. The band of claim 48, wherein said first end portion includes a
lateral member extending laterally from said first end portion
adjacent said end members, said retaining part including a second
opening configured to receive said lateral member.
51. The band of claim 51, wherein said second opening has a keyhole
shape having a wide portion and a narrow portion, and wherein said
lateral member includes an enlarged distal end configured to pass
through said wide portion.
Description
RELATED APPLICATIONS
[0001] This application claims priority from U.S. Provisional
Patent Application Ser. No. 60/483,353, titled Adjustable Gastric
Band Having An Improved Attachment Mechanism, filed on Jun. 27,
2003, and U.S. Provisional Patent Application Ser. No. 60/507,625,
titled Implantable Band Having Improved Attachment Mechanism, filed
on Sep. 30, 2003, the disclosures of both of which are incorporated
herein by reference. This application also incorporates by
reference co-pending U.S. Patent Application filed of even date
herewith, application Ser. No. ______, titled Implantable Band With
Attachment Mechanism, inventors Byrum, Jambor, Conlon, Crawford,
Harper and Spreckelmeyer. This application also incorporates by
reference the following co-pending U.S. patent applications filed
on Sep. 30, 2003: application Ser. No. 10/677,088, titled
Implantable Band with Transverse Attachment Mechanism, inventors:
Byrum, Jambor and Crawford; application Ser. No. 10/676,368, titled
Implantable Band with Non-Mechanical Attachment Mechanism,
inventors: Byrum and Nuchols; Provisional Application Ser. No.
60/507,916, Implantable Band with Attachment Mechanism, inventors:
Byrum, Jambor, Conlon, Crawford, Harper and, Spreckelmeier; and
Provisional Application Ser. No. 60/507,916, Implantable Band with
Deformable Attachment Mechanism, inventors: Byrum, Wiley, Conlon
and Fender.
TECHNICAL FIELD
[0002] This present invention relates generally to a surgically
implantable band for encircling an anatomical passageway, and is
particularly directed to an adjustable gastric band for encircling
the stomach for the control of obesity. The invention will be
specifically disclosed in connection with an improved attachment
mechanism for an adjustable gastric band.
BACKGROUND OF THE INVENTION
[0003] Since the early 1980s, adjustable gastric bands have
provided an effective alternative to gastric bypass and other
irreversible surgical weight loss treatments for the morbidly
obese. The gastric band is wrapped around an upper portion of the
patient's stomach, forming a stoma that is less than the normal
interior diameter of the stomach that restricts food passing from
an upper portion to a lower digestive portion of the stomach. When
the stoma is of the appropriate size, food held in the upper
portion of the stomach provides a feeling of fullness that
discourages overeating.
[0004] In addition to a latched position to set the diameter of the
gastric band, adjustability of gastric bands is generally achieved
with an inwardly directed inflatable balloon, similar to a blood
pressure cuff, into which fluid, such as saline, is injected
through a fluid injection port to achieve a desired diameter. The
balloon is typically deflated or only partially inflated when first
placed in the body to allow for body adjustments and healing around
the new band site. Since adjustable gastric bands may remain in the
patient for long periods of time, the fluid injection port is
typically installed subcutaneously to avoid infection, for instance
in front of the sternum. Following the initial implantation, the
surgeon may adjust the band by loosing or tightening depending on
the patients' needs. Adjusting the amount of fluid in the
adjustable gastric band is achieved by inserting a Huber tip needle
through the skin into a silicone septum of the injection port. Once
the needle is removed, the septum seals against the hole by virtue
of compressive load generated by the septum. A flexible conduit
communicates between the injection port and the adjustable gastric
band.
[0005] An attachment mechanism for the adjustable gastric band has
to provide an initial sizing of the stoma of the stomach. One
generally known attachment is to suture ends of the adjustable
gastric band. Another generally known attachment includes one end
of the gastric band terminating in a flexible conduit that has a
flared portion that is drawn through an opening in a second end of
the gastric band and then sutured to the encircling band
portion--securing the band to the stomach. After the sutures are in
place, the injection port is anchored at a convenient location.
[0006] While these known approaches are effective in securing the
gastric band, further improvements are desired that simplify the
clinical implantation procedure, that provide long-term
reliability, and that facilitate readjustment or removal.
[0007] While sutures have been relied on as the most positive
connection in the past, it is desirable to have a secure attachment
that does not require sutures, yet does not require a large force
to create the secure attachment. Otherwise, it may be difficult to
adequately grip and perform the attachment with laparoscopic
instruments. Consequently, a significant need exists for an
adjustable gastric band having an improvement attachment
mechanism.
SUMMARY OF THE INVENTION
[0008] The present invention addresses these and other problems in
the prior art, by providing an adjustable gastric band device that
is engaged with less force, thereby facilitating implementation
with laparoscopic instruments, yet the attachment remains secure
over long term use.
[0009] A general object of this invention is to provide an
adjustable gastric band where insertion of a second end into a
first end requires a low amount of force, and a lock element is
engaged so that a very high amount of force is required to separate
the two ends.
[0010] Another object of this invention is to provide a readily
reversible adjustable gastric band which can be fastened and
unfastened without reducing the holding strength of the attachment
mechanism.
[0011] Another object of this invention is to provide an adjustable
gastric band having longitudinal forces that are transferred
through the attachment mechanism that may be relatively large
without causing detachment, while engagement forces are relatively
low.
[0012] To achieve the foregoing and other objects, and in
accordance with the purposes of the present invention as described
herein, there are described adjustable gastric bands with opposing
surface attachment mechanisms having a member extending laterally
from one end which is configured to engage the other end. In
accordance with one aspect, the lateral member includes a
passageway which receives a portion of the other end. In another
aspect, the lateral member is received by an opening in the other
end.
[0013] In the present invention, an adjustable gastric band is
provided with a two-step attachment mechanism that allows an
initial attachment to confirm placement, followed by a second
engagement to give a visual indication of a secure attachment and
to add to the strength of the attachment.
[0014] Further novel features and other objects of the present
invention will become apparent from the following detailed
description, discussion and the appended claims, taken in
conjunction with the drawings.
BRIEF DESCRIPTION OF THE FIGURES
[0015] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate embodiments of
the invention, and, together with the general description of the
invention given above, and the detailed description of the
embodiments given below, serve to explain the principles of the
present invention.
[0016] FIG. 1 is a diagrammatic drawing showing an adjustable
gastric band wrapped around an upper part of a stomach.
[0017] FIG. 2 is a cross sectional view of the adjustable gastric
band of FIG. 1 taken along line 2-2.
[0018] FIG. 3 is a top view of an adjustable gastric band
constructed in accordance with the present invention having an
attachment mechanism which requires two steps to connect the two
ends together.
[0019] FIGS. 4A-D are a sequence of fragmentary side views of the
ends of the adjustable gastric band of FIG. 3, illustrating the
steps in securing the ends together.
[0020] FIG. 5 is an enlarged, cross section side view of the
adjustable gastric band of FIG. 3 taken along line 5-5 of FIG.
4D.
[0021] FIG. 6 is a top plan view of another embodiment of an
adjustable gastric band constructed in accordance with the present
invention having a two step attachment mechanism.
[0022] FIG. 7 is an enlarged, fragmentary top view of the two step
attachment mechanism shown in FIG. 6, in an unengaged
condition.
[0023] FIG. 7A is an enlarged, fragmentary perspective view taken
along line 7A of FIG. 7.
[0024] FIG. 8 is an enlarged, fragmentary top view of another
embodiment of a two step attachment mechanism constructed in
accordance with the present invention.
[0025] FIGS. 9A & 9B are a sequence of fragmentary top views of
another embodiment of a two step attachment mechanism constructed
in accordance with the present invention, illustrating the steps in
securing the ends together.
[0026] FIG. 10 is a side view of the adjustable gastric band as
shown in FIG. 9B.
[0027] FIG. 11 is an enlarged, fragmentary perspective view of
another embodiment of a two step attachment mechanism constructed
in accordance with the present invention
[0028] FIGS. 12A & 12B are a sequence of fragmentary top views
of the embodiment shown in FIG. 11, illustrating the steps in
securing the ends together.
[0029] FIG. 13 is an enlarged, fragmentary perspective view of
another embodiment of a two step attachment mechanism constructed
in accordance with the teachings of the present invention, with the
two end portions engaged.
[0030] FIG. 14 is an enlarged, fragmentary perspective view of the
outer surface of the embodiment shown in FIG. 13, with the two end
portions unengaged.
[0031] FIG. 15 is an enlarged, fragmentary perspective view of the
inner surface of the embodiment shown in FIG. 13, with the two end
portions unengaged.
[0032] Reference will now be made in detail to the present
preferred embodiment of the invention, an example of which is
illustrated in the accompanying drawings.
DETAILED DESCRIPTION OF THE INVENTION
[0033] In the following description, like reference characters
designate like or corresponding parts throughout the several views.
Also, in the following description, it is to be understood that
terms such as front, back, inside, outside, and the like are words
of convenience and are not to be construed as limiting terms.
Terminology used in this patent is not meant to be limiting insofar
as devices described herein, or portions thereof, may be attached
or utilized in other orientations. Referring in more detail to the
drawings, the invention will now be described.
[0034] Referring to FIG. 1, an adjustable gastric band 10 is shown
wrapped around an upper portion of a stomach 12, kept in place by
attaching the two ends together and extending a portion 14 of the
stomach 12 over the adjustable gastric band 10 by suturing portion
14 to the stomach. Referring also to FIG. 2, the adjustable gastric
band 10 includes a non-extensible strap 16 and an inflatable
balloon 18, made of a medical grade silicone polymer or any other
suitable material, is carried by the inner surface 20 of the strap
16. The balloon 18 may be secured to the inner surface 20 in any
well known manner, or even made of unitary construction with the
strap 16, although the strap 16 may typically be formed of a
different material.
[0035] One end of a flexible conduit 22 is in fluid communication
with the internal cavity 24 of the balloon 18, with the other end
being in fluid communication with an internal cavity (not shown) of
a remote injection port 26. The remote injection port 26 includes a
silicone septum 28. At the time the adjustable gastric band 10 is
implanted around a portion of the stomach, the remote injection
port 26 is also implanted at a suitable location, usually within
the rectus sheaths, for transcutaneous access via a Huber
needle.
[0036] As is well known, the internal cavity 24, the flexible
conduit 22 and the internal cavity of the remote injection port 26
are preferably at least partially filled with a physiologically
compatible fluid, such as a saline solution. Postoperative
adjustment of the perimeter enclosed by the balloon 18, and
therefore the size of the stoma, is accomplished by addition or
removal of fluid from the interior cavity 24 of the balloon 18 by
inserting a Huber needle percutaneously into the silicone septum 28
of the injection port 18.
[0037] As is well known in the field the adjustable gastric band 10
may be made from any suitable medically compatible material having
sufficient strength necessary for a particular laparoscopic surgery
or particular patient.
[0038] As mentioned above, the two ends of the adjustable gastric
band 10 are attached together (the specific attachment mechanism
structure is not illustrated in FIG. 1). The present invention is
directed to various embodiments of attachment mechanisms for
connecting the two ends together in which there are two steps
required to attach the ends together. The general construction of
adjustable gastric band 10 shown in FIGS. 1 and 2 and described
above is common to the embodiments illustrated in FIGS. 3-14, with
the embodiments differing by the specific attachment mechanisms. It
is noted that the practice of the present invention may be used
with any band, and is not limited to use with an adjustable gastric
band having the exact features described above or below.
[0039] Turning now to FIG. 3, the adjustable gastric band 30
includes an elongated strap 32 extending in what is referred to
herein as the longitudinal direction, even though when implanted
the adjustable gastric band 30 has an arcuate configuration. The
strap 32 includes an inner surface 34 and an outer surface 36, with
the balloon 38 extending inwardly from adjacent the inner surface
34. The adjustable gastric band 30 includes a first end portion 40
which overlaps a second end portion 42, with the inner surface 34
of the adjustable gastric band 30 at the first end portion 40 being
disposed adjacent and outside the outer surface 36 of the
adjustable gastric band 30 at the second end 42 portion.
[0040] Referring also to FIG. 4A, the first and second end portions
40, 42 are secured together by a two step attachment mechanism. The
first end portion 40 of the strap 32 terminates in an elongated
member 44. The elongated member 44 includes a doughnut-shaped
enlarged portion 46, having an opening 48 formed therethrough. The
enlarged portion 46 has cutouts 50 configured to allow an
instrument to grasp the enlarged portion 46 to maneuver it as
needed.
[0041] The elongated member 44 includes two enlarged, spaced apart
spherical portions 52a, 52b disposed at the distal end of elongated
member 46, in a barbell configuration, with a portions 44a, 44b of
elongated member 44 extending between spherical portions 52a and
52b, and between spherical portion 52b and enlarged portion 46,
respectively. It will be appreciated that portions 52a and 52b are
not limited to a spherical shape, and may be any suitable
shape.
[0042] Extending from the outer surface 36 of the second end
portion 42 of the strap 32 is at least one laterally extending
member 54 which is configured to engage the first end portion 40.
The laterally extending member 54 defines a passageway 56, also
referred to herein as an opening, through which the first end
portion 40 is configured to extend in a longitudinal direction. The
passageway 56 has a cross sectional shape and size which is
complementary to the cross sectional shape and size of the
elongated member 44. At least one dimension of the passageway 56 is
smaller than the corresponding dimension of the enlarged portion
46, and in the depicted embodiment, the passageway 56 is smaller in
both height and width. The passageway 56 is also depicted as being
smaller in both height and width than the spherical portions 52a
and 52b, although the passageway 56 may alternatively be large
enough for portions 52a and 52b to pass therethrough without any
resistance.
[0043] The distal end of the second end portion 42 has two spaced
apart tabs 58, 60 having angled surfaces 58a, 60a and transverse
surfaces 58b, 60b, which together form a notch 62 when viewed from
above. The first end portion 40 includes corresponding surfaces
64a, 64b, 66a and 66b which are shaped complementarily to and
engage notch 62 when the two end portions 40, 42 are engaged, as
described below. The second end portion 42 also includes an opening
or recess 68 formed in the outer surface 36. The recess 68 is
shaped complementary to and receives the spherical end portion 52a,
as described below.
[0044] The first step in engaging the two step attachment mechanism
together is to activate the first latching mechanism to attach the
first end portion 40 to the second end portion 42, by pulling the
elongated member 44, including the spherical portions 52a, 52b and
the enlarged portion 46 through the passageway 56. Although the
dimensions of the passageway 56 relative to the portions 44a, 44b
and the spherical portions 52a, 52b may allow the distal end of the
elongated member 44 to be pushed through the passageway 56, in the
embodiment depicted, the distal end of the elongated member 44 is
pulled through the passageway 56 using an instrument, such as a
grasper, to engage at least the spherical portion 52a.
[0045] Referring to FIG. 4B, the spherical portions 52a, 52b have
been pulled completely through the passageway 56, with the enlarged
portion 46 still partially disposed therein. As shown, the enlarged
portion 46 and the lateral member 54 elastically deform during this
first step.
[0046] FIG. 4C illustrates the configuration of the two step
attachment mechanism in-between the first and second steps of the
engagement process, with the enlarged portion 46 having been pulled
almost completely through the passageway 56, and the surfaces 64a,
64b, 66a and 66b urged into engagement with the notch 62 to provide
transverse stability. With the first latching mechanism so
activated by the first step, the final circumferential
size/diameter of the band has been established. Alternatively, the
length of portion 44c of the elongated member 44 may be sized such
that the enlarged portion 46 is completely outside of the
passageway 56, although preferably the surfaces 64a, 64b, 66a and
66b are urged into engagement with the notch 62.
[0047] The second step of engaging the two step attachment
mechanism together is to activate the second latching mechanism to
maintain the first end portion 40 attached to the second end
portion 42, as a back up to the first latching mechanism, in the
event of a failure of the first latching mechanism, either by
engagement with the second end portion 42, or, as shown in this
embodiment, with the first end portion 40. Referring to FIGS. 4C,
4D and 5, the spherical portion 52a is inserted through opening 48
into the position shown in FIGS. 4D and 5, with respective parts of
the spherical portions 52a, 52b extending past the upper and lower
surfaces 46a, 46b, with part of the spherical portion 52a disposed
in the recess 68. The opening 48 is sized such that, in combination
with the elasticity of the enlarged portion 46, the spherical
portions 52a, 52b are retained in the position shown in FIG. 5.
Thus, the spherical portions 52a, 52b and portion 44a comprise a
retaining part of the first end portion 40 which cooperates with
and engages another part of the first end portion 40, the opening
48. It is noted that portion 44a may be disposed in a variety of
positions, including at or near midway between upper and lower
surfaces 46a and 46b.
[0048] In the embodiment depicted in FIG. 5, the size of the
enlarged portion 46 relative to the passageway 56 may be sufficient
to retain the band, with the second integral latching mechanism
functioning as a back up. The second latching mechanism resists
disengagement of the two end portions 40, 42 due to a longitudinal
force by the lateral orientation of the retaining part of the first
end portion 40.
[0049] FIG. 6 illustrates another embodiment of an adjustable
gastric band having a two step attachment mechanism. The adjustable
gastric band 70 includes an elongated strap 72 having an inner
surface 74 and an outer surface 76, with the balloon 78 extending
inwardly. The adjustable gastric band 70 includes a first end
portion 80 which overlaps a second end portion 82, with the outer
surface 76 at the first end portion 80 being disposed adjacent the
outer surface 76 at the second end 82 portion.
[0050] Referring also to FIG. 7, which illustrates the first and
second end portions 80, 82 in an unengaged condition, the first end
portion 80 includes a lateral passageway 84, also referred to
herein as an opening, which is configured to have the second end
portion 82 inserted therethrough. The first end portion 80 also
includes two lateral openings 86, 88. The second end portion 82
includes a retaining part 90 comprising the two spaced apart
laterally extending members 92, 94 each having an enlarged portion
92a, 94a at the respective distal ends. The two lateral openings
86, 88 are sized and shaped to cooperate with the members 92, 94,
retaining them after the enlarged portions 92a, 94a have been
pushed through, as seen in FIG. 6.
[0051] The transverse dimension of the second end portion 82 which
extends beyond the lateral passageway 84 may be larger than the
corresponding transverse dimension of the lateral passageway 84. To
achieve this, the second end portion may be notched, having a neck
portion 82a with a reduced transverse dimension which is
approximately the same as the transverse dimension of the lateral
passageway 84. In this configuration, at either end of the neck
portion 82a there are spaced apart generally transversely extending
surfaces 82b and 82c. Alternatively, the transverse dimension of
the second end portion 82 may be constant along its length,
approximately the same as the lateral dimension of the lateral
passageway 84. Or, the second end portion 82 could have two or more
transverse dimensions, stepping up at surface 82b (with no
corresponding surface 82c) from a transverse dimension which is
approximately the transverse width of the lateral passageway 84 to
a transverse dimension greater than the transverse dimension of the
lateral passageway 84
[0052] The first step in engaging the two end portions 80, 82, is
activating the first latching mechanism by inserting the second end
portion 82 through the opening 84, past the lateral member 94,
until the neck portion 82a extends through the lateral passageway
84, with the surfaces 82b adjacent the outer surface 76 of first
end portion 80. With the first latching mechanism so activated by
the first step, the final circumferential size/diameter of the band
has been established. The surfaces 82b and 82c preclude significant
movement between the first and second end portions 80, 82 following
the first step. The surfaces 82b are important in this
configuration of this embodiment to establish the maximum final
diameter, and the surfaces 82c may be omitted or located further
away from the surfaces 82b without affecting this.
[0053] The second step is activating the second latching mechanism
by engaging the retaining part 90 with the first end portion 80,
inserting the members 92, 94 into the respective openings 86, 88,
further retaining the first end portion 80 in place, backing up the
first latching mechanism, such as in the event it fails, completely
or partially. As will be appreciated, one or more than two lateral
members and corresponding cooperating openings may be used, as well
as different shapes which cooperate together to remain in
engagement.
[0054] FIG. 8 illustrates another embodiment of an adjustable
gastric band having a two step attachment mechanism. In FIG. 8,
only the first and second end portions 96, 98 are illustrated
engaged together, with the inner surface 100 at the first end
portion 96 being disposed adjacent the inner surface 100 at the
second end 98 portion. The second end portion 98 includes at least
one laterally extending member 102 which is configured to engage
the first end portion 96. The laterally extending member 102
defines a passageway 104, also referred to as an opening, through
which the first end portion 96 is configured to extend in a
longitudinal direction.
[0055] The second end portion 98 includes a lateral opening 106 and
a retaining member 108. Retaining member 108, as depicted, is of
unitary construction with second end portion 98, although it could
be formed separately and attached in any suitable manner. The
distal end of the retaining member 108 includes an arm 110 which
terminates in a member or pin 112 having a flared tip 114. The arm
110 and its connection to the second end portion 98 allows the arm
to be rotated to move the pin 112 into alignment with and through
the opening 106. The connection between the arm 110 and the second
end portion 98 may be configured in any manner suitable for the arm
110 to be rotated as described, including for example a living
hinge.
[0056] The first end portion 96 is sized to extend through the
passageway 104 in the longitudinal direction as shown. The first
end portion also includes a lateral opening 116.
[0057] The first step in engaging the two end portions 96, 98, is
inserting the second end portion 96 through the opening 104, to a
position at which the opening 116 is aligned with the opening 106.
The second step is retaining the first end portion 96 in place by
moving the retaining member 108 to advance the pin 112 into the
openings 106, 116, such that the large (relative to opening 116)
flared tip 114 keeps the pin 112 from backing out of the openings
116 and concomitantly 106.
[0058] Alternatively, the retaining member 108 could carried by the
first end portion 96 extending over the member 102 to extend
through the openings 116, 106 with the flared tip 114 sized to keep
the pin 112 from backing out of the opening 106 and concomitantly
116. Also, the opening 106 could be omitted by shortening the
second end portion 98 to clear the pin 112 and flared tip 114. A
plurality of longitudinally spaced openings formed in the end
portion not carrying the retaining member 108 may be used to
adjustable sizing of the adjustable gastric band.
[0059] Additionally, a portion of the first end portion 96 could
have an increased transverse dimension larger than the transverse
dimension of the opening 104, forming a step which abuts the end
102a of the laterally extending member 102. In such a
configuration, the first step activates the first latching
mechanism formed by the cooperation of such steps and the end 102a,
establishing the final circumferential size/diameter of the band.
The second step, which backs up the first latching mechanism.
[0060] FIGS. 9A, 9B and 10 illustrate another embodiment of an
adjustable gastric band having a two step attachment mechanism. In
FIG. 9A only the first and second end portions 118, 120 are
illustrated, partially engaged following the first attachment step.
The first end portion 118 includes an elongated member 122 which
terminates in a retaining part 124 having an arrowhead shape with a
wide base 124a from which the leading edges 124b, 124c extend
longitudinally to converge at the narrow tip 124d. As seen in FIG.
10, the base 124a has an arcuate lateral profile, from which
surfaces 124e, 124f extend to converge at tip 124d. Although first
end portion 118 is illustrated as arcuate where member 122 extends,
it may be any suitable shape.
[0061] Second end 120 includes an opening 126 formed at its distal
end, and a pair of spaced apart laterally extending members 128,
130, spaced down from the opening 126. Each laterally extending
member 128, 130 includes a laterally extending portion 128a, 130a,
connected to a longitudinally extending member 128b, which
cooperate with the upper surface 132 of the adjustable gastric band
to create an opening 134, 136. The openings 134, 136 are configured
to retain the base 124a of retaining part 124, which may include
the portions 128b, 130b having lower surfaces inclined toward the
outer surface 132.
[0062] The first step in engaging the two end portions 118, 120, is
inserting the first end portion 118 through the opening 126,
advancing it until the edge 138 is urged into contact with the
lower surface 140 of the second end portion 120 adjacent the
opening 126, with the distal end 142 of second end portion 120
being bent up slightly, as seen in FIG. 10. The second step is
retaining the first end portion in place by engaging the retaining
part 124 with the second end portion 120, inserting the retaining
part 124 into the respective openings 134, 136, locating the base
124a as shown in FIG. 10. The length of member 122 urges distal end
142 toward the bent position shown.
[0063] It is noted that retaining part 124 is not limited to an
arrowhead shape, and any shape which may be inserted through an
opening in the second end portion and function as a retaining
member may be used.
[0064] FIG. 11 illustrates another embodiment of an adjustable
gastric band having a two step attachment mechanism. In FIG. 11,
only the first and second end portions 144, 146 are illustrated,
disengaged. First end portion 144 terminates in a transversely
extending member 148 connected to the rest of the first end portion
144 by a strap 150 through a living hinge 152. A retaining part 154
extends from the strap portion 150, angled away from the member
148, as shown in FIG. 11. The retaining part 154 includes a key
hole shaped opening 156.
[0065] The distal end 158 of the second end portion 146 includes
two longitudinally extending spaced apart members 160, 162 which
define two spaced apart, aligned openings 164, 166. As seen in FIG.
12A, the openings 164, 166, are shaped complementarily to the
member 148 to rotatably receive the member 148, having respective
entrance edges 168, 170 which have smaller dimensions than the
corresponding dimensions of the member 148.
[0066] The second end portion 146 includes a laterally extending
member 172, depicted in the shape of a rivet, having a head 174
which is larger than the base 176. Member 172 and opening 156 are
configured to cooperate together.
[0067] Referring to FIG. 12A, the first step in engaging the two
end portions 144, 146, is inserting member 148 into openings 164,
166, which may be done by disposing the member 148 adjacent the
entrance edges 168, 170 and applying a longitudinal force
sufficient to expand the entrance temporarily until member 148
snaps into place. FIG. 12A illustrates the two step attachment
mechanism between the first a
[0068] The second step is engaging the retaining part 154 with the
second end portion 172. The cylindrical member 148 is rotated
within openings 164, 166 by moving the retaining part 154 toward
the second end portion 146, causing the strap 150 to pivot about
the living hinge 152. The head 174 is inserted through the large
part 156a of the opening 156, and the base 176 is slide into the
small part 156b, thereby retaining the retaining part 154.
[0069] FIGS. 13, 14 and 15 illustrate another embodiment of an
adjustable gastric band having a two step attachment mechanism. In
FIGS. 13-15, only the first and second end portions 178, 180 are
illustrated. The first end portion 178 includes a lateral
passageway 182, also referred to herein as an opening, which is
configured to have the second end portion 180 inserted
therethrough. The second end portion 180 includes a retaining part
184 comprising a member 186 extending laterally from the outer
surface 188. The stem member 186 includes an enlarged head portion
190 at its distal end.
[0070] Second end portion 180 includes a lateral opening 192 spaced
from the retaining part 184 toward the end 180a. In the
illustration, the opening 192 has a key way shape with an enlarged
portion 194 having a generally circular shape and an elongate slot
portion 196 extending in a longitudinal direction. The portion 194
is shaped complementarily to the head portion 190, configured to
allow the head portion 190 to be inserted easily therethrough.
[0071] The slot 192 is shaped complementary to stem member 186. As
seen in FIGS. 16 and 17, member 186 extends in the longitudinal
direction, having a transverse dimension which is complementary to
the transverse dimension of the slot 192. In the embodiment
depicted, the stem member 186 extends from the edge 190a of the
head portion 190 to past the center of the head portion 190.
[0072] The second end portion 180 past is notched between retaining
member 184 and opening 192, having a neck portion 198 with a
reduced transverse dimension which is approximately the same as the
transverse dimension of the lateral passageway 182. In this
configuration, at either end of the neck portion 196, there are
spaced apart generally transversely extending surfaces 200, 202.
Alternatively, the transverse dimension of the second end portion
180 may be constant along its length, approximately the same as the
lateral dimension of the lateral passageway 182. Or, the second end
portion 180 could have two or more transverse dimensions, stepping
up at surface 202 (with no corresponding surface 200) from a
transverse dimension which is approximately the transverse width of
the lateral passageway 182 to a transverse dimension greater than
the transverse dimension of the lateral passageway 182.
[0073] The longitudinal dimension between the notch centerline
between surfaces 200 and 202 and the centerline of retaining member
184 is approximately equal to the longitudinal dimension between
the notch centerline and the center of the semicircular end
196a.
[0074] Referring to FIG. 13, the first step in engaging the two end
portions 178, 180, is activating the first latching mechanism by
inserting the second end portion 180 through the opening 182, past
the retaining member 184, until the neck portion 194 is disposed in
the opening 182. With the first latching mechanism so activated by
the first step, the final circumferential size/diameter of the band
has been established. The surfaces 200 and 202 preclude significant
movement between the fist and second end portions 178, 180.
[0075] The second step is activating the second latching mechanism
by inserting the retaining part 184 into the opening 192. The head
portion 190 is inserted into the portion 194 by pulling the end
180a to align the two. The tension on the second end portion 180
past the neck, or hinge portion, 194, causes the stem member 186 to
move into the slot portion 186 to abut end 196a. The tension is the
result of the approximately equal respective dimensions between the
centerline of the retaining member 184, the neck, or hinge portion,
194, and the centerline of the end 196a. The second step backs up
the first latching mechanism.
[0076] It will become readily apparent to those skilled in the art
that the above invention has equally applicability to other types
of implantable bands. For example, bands are used for the treatment
of fecal incontinence. One such band is described in U.S. Pat. No.
6,461,292 which is hereby incorporated herein by reference. Bands
can also be used to treat urinary incontinence. One such band is
described in U.S. Patent Application 2003/0105385 which is hereby
incorporated herein by reference. Bands can also be used to treat
heartburn and/or acid reflux. One such band is described in U.S.
Pat. No. 6,470,892 which is hereby incorporated herein by
reference. Bands can also be used to treat impotence. One such band
is described in U.S. Patent Application 2003/0114729 which is
hereby incorporated herein by reference.
[0077] Thus, as used herein and in the claims, an implantable band
is a band which may be implanted in a position to occlude flow,
such as food or body fluids, through an anatomical passageway, such
as a stomach or lumen.
[0078] In summary, numerous benefits have been described which
result from employing the concepts of the invention. The foregoing
description of one or more embodiments of the invention has been
presented for purposes of illustration and description. It is not
intended to be exhaustive or to limit the invention to the precise
form disclosed. Obvious modifications or variations are possible in
light of the above teachings. The one or more embodiments were
chosen and described in order to best illustrate the principles of
the invention and its practical application to thereby enable one
of ordinary skill in the art to best utilize the invention in
various embodiments and with various modifications as are suited to
the particular use contemplated. It is intended that the scope of
the invention be defined by the claims appended hereto.
* * * * *